Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Phase 1

Terminated

• Conditions: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: riluzole; Radiation: whole-brain radiation therapy

• Registration Number: NCT01018836
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs, such as riluzole, may make tumor cells more sensitive to radiation therapy. Giving riluzole together with whole-brain radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of riluzole when given together with whole-brain radiation therapy in treating patients with brain metastases.

Detailed Description

OBJECTIVES:

Primary

* To determine the maximum tolerated dose of riluzole that can be administered concurrently with standard whole-brain radiotherapy (WBRT) in patients with multiple brain metastases.

Secondary

* To determine the long-term toxicity of riluzole when administered with WBRT.

* To assess neurocognitive function before and after treatment with riluzole and WBRT.

* To determine the MRI response of brain metastasis after treatment with riluzole and WBRT.

* To compare survival of patients treated with riluzole and WBRT to published historical data for patients with brain metastases.

* To evaluate the response of brain metastasis to riluzole and WBRT as a function of the expression of glutamate receptors on the primary tumor specimen.

OUTLINE: This is a dose-escalation study of riluzole.

Patients receive oral riluzole twice daily beginning on day 0. Beginning within 2 days after the initiation of riluzole, patients undergo whole-brain radiotherapy for 15 fractions.

Patients undergo neurocognitive and quality-of-life assessments at baseline, at 5 weeks, and at 3 months.

Tumor tissue samples are collected for laboratory biomarker studies.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Riluzole; Radiation Therapy	whole-brain radiation therapy	-
Riluzole; Radiation Therapy	riluzole	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of riluzole	2.5 years

Secondary Outcome Measures

Name	Time	Method
Long-term toxicity of riluzole	.25 years
Neurocognitive function before and after treatment	2.5 years
MRI response of brain metastasis after treatment	2.5 years
Survival	2.5 years
Response of brain metastasis to treatment as a function of the expression of glutamate receptors	2.5 years

Trial Locations

Locations (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States